BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOCODE METER

    MDR report key: 4417441 · Received January 12, 2015

    Report

    Report Number
    3008789114-2014-00036
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 7, 2015
    Manufacturer
    OK BIIOTECH CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3008789114-2014-00036 TO SUBMIT ADDITIONAL INVESTIGATIVE INFORMATION FROM MANUFACTURER OF THE SUSPECT DEVICE. RESULTS ARE AS FOLLOWS: SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CONCLUDED THAT THE METER AND STRIPS ARE OPERATED WITHIN SPECIFICATIONS. THE METER CURRENT TEST IS 0.9UA. THE CRITERIA IS <55UA. METER SETTING, AUDIO AND ALL BUTTONS WERE OK. TESTED THE SUSPECTED METER WITH SUSPECTED STRIP AND RETAINED STRIPS WITH IN HOUSE CONTROL SOLUTION. THE READINGS OF CONTROL SOLUTION TEST FOR LOW LEVEL ARE: 41/45/46/44 MG/DL; FOR HIGH LEVEL ARE: 235/240/262/255 MG/DL, THE REQUEST GCS RANGE IS LOW: 25~70 MG/DL; HIGH: 200~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE. REFERENCE MANUFACTURER REPORT # 3005862821-2015-00001. (B)(6).

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON 12/18/2014 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2014 AROUND 2-3 AM. PT (B)(6) STATED HER BLOOD GLUCOSE LEVEL HAD DROPPED TO 26 MG/DL. PT STATED SHE WAS HAVING SYMPTOMS OF STOMACH DISCOMFORT AND ITCHING. FROM PREVIOUS EXPERIENCE THE SYMPTOMS LED HER TO BELIEVE HER BLOOD GLUCOSE WAS DROPPING. PT CALLED HER HUSBAND THEN PASSED OUT. PT STATED THAT THE PRODIGY METER GAVE HER A FALSE READING OF 500 MG/DL, SO SHE TOOK INSULIN AND HER BLOOD GLUCOSE DROPPED TO 26 MG/DL. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 26 MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AND PERFORMED A GLUCOSE TEST WITH A READING OF "LO". APPROXIMATELY 15 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PT WAS NOT TRANSPORTED TO ER, BUT WAS GIVEN B50 INJECTION. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27678 AUTOCODE METER BLOOD GLUCOSE MONITORING DEVICE NBW OK BIIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R BUPROPION 150 MG X1| PREDNISONE 5 MG X1| PANTOPRAZOLE 40 MG X1| PRAVASTATIN 40 MG X1| CAPOTEN 600 MG| TACROLIMUS 1 MG X1| ESCITALOPRAM 20MG X1| NOVOLOG 8 UNITS WITH EACH MEAL| LANTUS 18 UNITS AT NIGHT